news

Axonics Modulation Technologies, Inc. announced today that it received marketing approval from the Australian Department of Health, Therapeutic Goods Administration (TGA) for the first rechargeable Sacral Neuromodulation (r-SNM™) System® to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.

This approval confirms that the Axonics r-SNM System meets all of the Australian Medical Devices Regulations for Active Implantable Medical Devices and enables commercialization throughout Australia.

“Australian TGA approval provides Axonics with another important marketing approval. Along with our European CE mark and Health Canada approval, this gives us the ability to sell our product in three significant international territories while we complete our U.S. pivotal study,” said Raymond W. Cohen, Chief Executive Officer of Axonics.

Over five million people, or approximately 20% of the Australian population, experience bladder or bowel control problems, many of which are not provided with a suitable therapeutic option. Urinary incontinence tops the list with up to 37% of women affected (Australian Institute of Health and Welfare report, 2006).

In the U.S. and Europe, OAB affects an estimated 85 million adults with another 40 million reported to suffer from fecal incontinence. SNM therapy is an effective and durable treatment that has been widely used and reimbursed for the past two decades accounting for an estimated $700 million in revenue in 2017. SNM is the only OAB treatment with proven clinical superiority to standard medical therapy and OAB patients who receive SNM report significantly higher quality of life than patients undergoing drug treatment.